Dose Escalation of Lobaplatin Concurrent With IMRT for the Treatment of NPC: A Phase I Clinical Trial
NCT ID: NCT03188497
Last Updated: 2018-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2016-06-22
2018-03-20
Brief Summary
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Lobaplatin is the third generation platinum anticancer drugs, mechanism of action and traditional cisplatin is similar, mainly formed by the Pt-GG and Pt-AG chain cross connect, replication and transcription process blocks of deoxyribonucleic acid(DNA), thereby interfering with tumor cell cycle. The damage of DNA induced by lobaplatin can influence the expression of tumor cell specific genes. Due to the different structure of lobaplatin and no cross resistance to cisplatin in the study showed that, compared with cisplatin with gastrointestinal reaction more mild, and no cisplatin common liver and kidney toxicity, neurotoxicity and ototoxicity, in some tumors have a better adaptability; but compared with cisplatin had more severe bone marrow suppression this, offset some of the advantages of lobaplatin in a certain extent. At present, the clinical indications for the treatment of such diseases include head and neck cancer, breast cancer, gastrointestinal cancer, gynecologic malignant tumor and non small cell lung cancer. Tian Ying confirmed that lobaplatin has obvious cytotoxic effect on nasopharyngeal carcinoma cells, in a concentration dependent manner, the mechanism for the dual role, namely block at lower concentration of cells in G2 phase and induce apoptosis at higher concentration, provide the possibility for clinical treatment of nasopharyngeal carcinoma for lobaplatin; there are a number of clinical study confirmed that lobaplatin chemoradiotherapy for locally advanced nasopharyngeal carcinoma with cisplatin approximation. But at present, there is no report on the dose and tolerability of concurrent radiotherapy for nasopharyngeal carcinoma.
Therefore, a dose escalation trial was conducted to determine maximum tolerated dose of lobaplat in as a single agent combined with concurrent intensity-modulated radiotherapy in a Chinese population with locoregionally advanced NPC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Experience group 1
The dose of lobaplatin is 25mg/m2 on d1,d22,d43.
Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Experience group 2
The dose of lobaplatin is on d1,d22,d43.
Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Experience group 3
The dose of lobaplatin is on d1,d22,d43.
Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Experience group 4
The dose of lobaplatin is 40mg/m2 on d1,d22,d43.
Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Experience group 5
The dose of lobaplatin is 45mg/m2 on d1,d22,d43.
Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Experience group 6
The dose of lobaplatin is 50mg/m2 on d1,d22,d43.
Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Interventions
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Lobaplatin
Lobaplatin for Injection
linear accelerator
Medical linear accelerator
Eligibility Criteria
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Inclusion Criteria
2. Overall Stage III-IVB (according to the seventh edition of AJCC staging system).
3. Age between 18-65 years old.
4. There is no evidence of distant metastasis.
5. Eastern Cooperative Oncology Group performance status 0 or 1.
6. Normal marrow function: white blood count \> 4 \* 109/L, hemoglobin \> 90g/L, and platelet count \> 100 \* 109/L.
7. Normal liver function: total bilirubin (TBIL) and alanine aminotransferase (ALT) \<2 times the normal values.
8. Normal renal function: creatinine (Cr) \<1.5 times the normal value.
9. The patient must be the basic content of this research and the defendant signed the informed consent.
Exclusion Criteria
2. Age \> 65 years old, or \< 18 yeas old.
3. The purpose of treatment is palliative.
4. There was a history of malignancy, except for adequately treated basal cell carcinoma or squamous cell carcinoma, and carcinoma in situ of the cervix.
5. Women who are pregnant or lactating (for women of child-bearing age) should consider pregnancy tests; effective contraception should be emphasized during treatment）.
6. Previously received radiation therapy .
7. Primary and neck metastases were treated with chemotherapy or surgery.
8. Accompanied by other serious diseases may pose a greater risk or impact on test compliance.
18 Years
65 Years
ALL
No
Sponsors
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Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Xiwei XU
Clinical doctor
Principal Investigators
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Siyang Wang, bachelor
Role: STUDY_DIRECTOR
Fifth Hospital Affiliated to Sun Yet Sen universty
Locations
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the Fifth Hospital Affiliated to Sun Yat-Sen University
Zhuhai, Guangdong, China
Countries
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References
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Wang SY, Xu XW, Yao JJ, Peng PJ, Zhou B, Liu QD, Huang XP, Lin Z. Dose Escalation of Lobaplatin Concurrent with IMRT for the Treatment of Stage III-IVb NPC: A Phase I Clinical Trial. Transl Oncol. 2018 Aug;11(4):1007-1011. doi: 10.1016/j.tranon.2018.06.004. Epub 2018 Jun 29.
Other Identifiers
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zsu20170203
Identifier Type: -
Identifier Source: org_study_id
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